Clinical Research Coordinator – Ethics

Do you want to work for a world-renowned research institute that pushes the boundaries of biomedical science and health research? Right here in Montreal At the Research Institute of the McGill University Health Centre (RI-MUHC), you can be part of an organization focused on scientific discovery and innovation in patient-centered medicine. Join us today and make a difference

Job Description

RESEARCH INSTITUTE OF THE MUHC

The Research Institute of the McGill University Health Centre (RI-MUHC) is a world-renowned biomedical and hospital research centre. Located in Montreal, Quebec, the Institute is the research arm of the McGill University Health Centre (MUHC) affiliated with the Faculty of Medicine at McGill University. The RI-MUHC is supported in part by the Fonds de recherche du Québec - Santé (FRQS).

Position Summary

Department / Research Program: CVIS Research

The Chronic Viral Illness Service Research team has an active research program, conducting numerous clinical trials each year to provide innovative research to their patients. Under the immediate supervision of the CVIS Research Director and the CVIS Clinical Research Manager, the incumbent will be directly involved in several PI-Initiated and industry clinical trials and research studies, related to chronic viral illnesses such as HIV, HBV, HCV, STIs, and liver diseases. The Clinical Research Coordinator – Ethics & Regulatory Affairs will complete the below listed tasks at the Chronic Viral Illness Service of the McGill University Health Center.

General Duties

The position includes the following tasks, but are not limited to:

• Collaborates with internal (Researchers, research staffs, pharmacy, Research institution department, Quality Assurance, Hospital department and Division, clinic staff) and external ( CATALIS, other research sites, Pharmaceutical Industry Sponsor, CROs, etc.) stakeholders.

Ethics activities

• Responsible for Ethics initial preparation and submission via NAGANO up to REB full approval and MUHC Authorization,
• Review start-up package for completeness,
• Prepare study ICFs as per the MUHC REB templates and obtain Sponsor approval,
• Primary point of contact for research ethics committees,
• Follow-up with Feasibility assessment,
• Organize Site Initiation Visit,
• Responsible for ongoing ethics activities submission and approval as amendments, notifications, annual renewal, close-out report, deviations, Serious Adverse Events, etc.

Regulatory affairs activities

• Act as a resource for investigators and research staff on clinical trials regulations, GCP, HCD5, SOPs, etc.,
• Maintain Regulatory documentation and Investigator Site Files (ISF),
• Maintain research team regulatory certifications and Master Regulatory files,
• Assure timely completion and signatures of regulatory documents for trials,
• Prepare training synopsis & training logs for trials initiation and amendments,
• Responsible for Delegation of Authority logs.

Additional tasks

• Organize Site Initiation Visits, and other trials trainings,
• Optimize study start-up and amendment approval timelines,
• Follow-up/meet with the CRA during/after monitoring visits,
• Assist with Investigator Initiated Study ethics and regulatory affairs,
• Act as a resource for staff with questions regarding the review process and requirements,
• MSSS multicentric submission with other sites in Quebec,
• Comply with Good Clinical Practice, Health Canada division 5, MUHC Standard Operation Procedures, etc.,
• Respect different concurrent timelines,
• Prepare and lead institutional, sponsor and health agencies monitoring and audits.

Website of the organization

https://rimuhc.ca/en

Education / Experience

Education: Bachelor's Degree

Field of Study: Health sciences, Ethics, Public Health, Research on human, pharmacology

Other education considered an asset for this position: Certification in Ethics, GCP, HCD5, other research program, clinical trials certification

Work Experience: 2 years in clinical trials field

Required Skills

This position requires an advanced knowledge of oral and written French.

• An advanced knowledge of oral and written English is required, as the position requires regular and complex contact with researchers or international students who are exclusively proficient in English. The position also requires complex writing or in-depth analysis of documents in English related to a research project.
• Must be professional, possess a high degree of efficiency and self-motivation, and have a strong work ethic and respect of confidentiality,
• Excellent communication and interpersonnel skills